A Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SV003 in Healthy Participants.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-45
SponsorShanghai Synvida Biotechnology Co.,Ltd.

About this trial

The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of SV003 in healthy subjects.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body Mass Index (BMI): 18.5 ≤ Chinese participants ≤ 30 kg/m², 18.5 ≤ Caucasian participants ≤ 32 kg/m²; additionally, male participants must have a body weight ≥ 50 kg, and female participants ≥ 45 kg;

Healthy status: No evidence of active or chronic diseases in participants;

Ability to participate in the study, willingness to provide written informed consent, and compliance with study requirements.

Disqualifiers

Subjects with a history of chronic diseases or currently presenting with clinically significant systemic diseases;

Subjects who have experienced a serious disease within 1 month prior to drug administration, or with any disease that may relapse immediately during or after the study;

Subjects with designated examination results reaching a specified value;

Subjects with abnormal laboratory test results deemed clinically significant by the investigator;

Trial design

Design model

Sequential

Treatments tested in this trial

  • SV003

    Drug

    SV003:Single-dose

  • Placebo

    Drug

    Placebo : Single-dose

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SV003Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Treatment-Emergent Adverse Events

Adverse event type, incidence, duration

Time frame
Approximately 3 months

Secondary outcomes

1

Peak Plasma Concentration (Cmax)

PK (Pharmacokinetics)

Time frame
Approximately 3 months
2

Peak time(Tmax)

PK (Pharmacokinetics)

Time frame
Approximately 3 months
3

Area under the plasma concentration versus time curve (AUC)

PK (Pharmacokinetics)

Time frame
Approximately 3 months
4

half-life(T1/2)

PK (Pharmacokinetics)

Time frame
Approximately 3 months

Other outcomes

Sponsors and contacts

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